FDA WARNING_LETTER - Nantong Furuida Packaging Products Co., Ltd. - October 26, 2023

The FDA issued a Warning Letter to Nantong Furuida Packaging Products Co., Ltd. (FEI 3015509579) on November 17, 2023, following a review of records submitted in response to an April 3, 2023, request. The facility, an OTC drug product manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated under 21 U.S.C. 351(a)(2)(B).

A primary violation (21 CFR 211.84(d)(1) and 211.84(d)(2)) was the failure to test incoming active pharmaceutical ingredients (APIs) for identity, purity, strength, and quality. Specifically, the firm relied on supplier Certificates of Analysis (COAs) for isopropyl alcohol without qualifying the supplier or verifying COA information, only testing for appearance, odor, and concentration. The supplier's COA lacked methanol testing specifications, despite the risk of methanol contamination in pharmaceutical alcohol. The firm also failed to provide identity testing results for other raw materials.

Additionally, the firm failed to provide evidence of long-term stability studies to corroborate accelerated study projections for product expiry dates and lacked comprehensive stability program documentation.

The FDA strongly recommended engaging a qualified CGMP consultant (21 CFR 211.34)